Trial Outcomes & Findings for Vaginal Preparation Prior to Hysterectomy (NCT NCT03412734)

NCT ID: NCT03412734

Last Updated: 2021-01-11

Results Overview

Contamination is defined as having \>5000 bacteria within a culture

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 94 participants
• Primary outcome timeframe: 90 minutes from initial preparation
• Results posted on: 2021-01-11

Participant Flow

6 patients were excluded (3 - not randomized at the day of surgery; 3 - missing study consent).

Participant milestones

Measure	Chlorhexidine Group Patients randomized to the Chlorhexidine group will undergo pre-surgical vaginal aseptic preparation using 4% Chlorhexidine preparation solutions.	Iodine Group Those patients randomized to the povidone-iodine group will have their pre-surgical vaginal aseptic preparation performed using 10% povidone-iodine solution.
Overall Study STARTED	47	41
Overall Study COMPLETED	44	41
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Chlorhexidine Group Patients randomized to the Chlorhexidine group will undergo pre-surgical vaginal aseptic preparation using 4% Chlorhexidine preparation solutions.	Iodine Group Those patients randomized to the povidone-iodine group will have their pre-surgical vaginal aseptic preparation performed using 10% povidone-iodine solution.
Overall Study Incorrect labeling of samples	2	0
Overall Study Exclusion criteria - patient receiving Flagyl for treatment	1	0

Baseline Characteristics

Vaginal Preparation Prior to Hysterectomy

Baseline characteristics by cohort

Measure	Chlorhexidine Group n=44 Participants Chlorhexidine: Chlorhexidine preparation solutions	Iodine Group n=41 Participants Iodine: Iodine-based preparation solutions	Total n=85 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 10.9 • n=5 Participants	62.2 years STANDARD_DEVIATION 11.6 • n=7 Participants	59.8 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	41 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	42 Participants n=5 Participants	39 Participants n=7 Participants	81 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	44 Participants n=5 Participants	41 Participants n=7 Participants	85 Participants n=5 Participants
Bacterial Vaginosis (BV) positive	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 minutes from initial preparation

Population: Use participants with cultures at 90 minutes

Contamination is defined as having >5000 bacteria within a culture

Outcome measures

Measure	Chlorhexidine Group n=42 Participants Chlorhexidine: Chlorhexidine preparation solutions	Iodine Group n=41 Participants Iodine: Iodine-based preparation solutions
Number of Participants With Contamination	20 Participants	35 Participants

Adverse Events

Chlorhexidine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Iodine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catrina Crisp, MD MSc

TriHealth Inc.

Phone: 513-463-4300

Email: Catrina_Crisp@trihealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place